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Fundamentals of the EU IVD RegulationPTI
Under the Medical Device Directive (MDD), the majority of IVDs are self-declared devices. However, under the Medical Device Regulation (MDR) the majority will require some form of conformity assessment by a Notified Body. The soon-to-be implemented Regulation is drastically different to the current Directive as it imposes new requirements on manufacturers and other economic operators on areas such as conformity, device classification and documentation which impact the entire device life-cycle.
These are but a few of the significant changes to the European legislation applicable to IVDS and, in a highly regulated industry, the stakes are high for failure to comply. Throughout this course you will learn about the revised scope of the IVDR and the impact it will have on your organisation. You will cement this knowledge through case studies and comprehensive learning materials, ensuring you are prepared for, and compliant to, the upcoming changes.
Suitability - Who should attend?
This course is relevant to those moving into, or new to IVD regulatory affairs within an IVD company, such as:
- Regulatory Affairs
- Clinical Affairs
- Quality Management
- Project Management
- Quality Assurance
- Professionals looking for a complete update on the IVD requirements
- Anyone looking to obtain or enhance their understanding of the IVD requirements
Training Course Content
- Gain a comprehensive insight into the latest developments outlined in the new Regulation
- Understand how to classify your device and distinguish it from others
- Examine the roles and responsibilities of Competent Authorities, Notified Bodies and Economic Operators
- Critically analyse the various conformity assessment routes
- Learn about the key updates to post-market surveillance and vigilance activities
- Recognise the differences between a technical file and a design dossier and how to compile them
- Study the updated labelling and CE marking requirements for your device
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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